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Ondansetron for the Treatment of Methamphetamine Dependence - 1
This study has been completed.
Sponsors and Collaborators: National Institute on Drug Abuse (NIDA)
University of Texas
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00040053
  Purpose

The purpose of this study is to assess ondansetron for the treatment of methamphetamine dependence.


Condition Intervention Phase
Amphetamine-Related Disorders
Drug: Ondansetron
Phase II

MedlinePlus related topics: Methamphetamine
Drug Information available for: Ondansetron Ondansetron hydrochloride Amphetamine Methamphetamine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Dose Comparison
Official Title: Double-Blind, Placebo-Controlled, Dose Response Trial of Ondansetron for the Treatment of Methamphetamine Dependence.

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Clinicial improvement

Estimated Enrollment: 154
Study Start Date: June 2002
Study Completion Date: February 2004
Detailed Description:

This study was designed to be a preliminary assessment of the efficacy and safety of 3-wide range doses of ondansetron (0.25, 1.0 and 4.0 mg taken orally twice per day) to reduce methamphetamine use in subjects with methamphetamine dependence and to determine the optimal dose of ondansetron.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

18 years of age. Treatment seeking for meth dependence.

Exclusion Criteria:

Please contact site director for more details.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00040053

Locations
United States, California
Matrix Institute on Addictions
Costa Mesa, California, United States, 92627
South Bay Treatment Center
Chula Vista, California, United States, 91911
United States, Hawaii
John A. Burns School of Medicine
Honolulu, Hawaii, United States, 96813
United States, Iowa
Powell Chemical Dependency Center
Des Moines, Iowa, United States, 50316
United States, Missouri
University of Missouri - Kansas City
Kansas City, Missouri, United States, 64108
United States, Texas
University of Texas Health Science Center
Houston, Texas, United States, 77225
Sponsors and Collaborators
University of Texas
Investigators
Principal Investigator: Thomas Newton, M.D. National Institute on Drug Abuse (NIDA)
  More Information

Study ID Numbers: NIDA-CTO-0011-1
Study First Received: June 18, 2002
Last Updated: July 21, 2008
ClinicalTrials.gov Identifier: NCT00040053  
Health Authority: United States: Federal Government;   United States: Food and Drug Administration

Study placed in the following topic categories:
Methamphetamine
Dopamine
Mental Disorders
Amphetamine-Related Disorders
Substance-Related Disorders
Disorders of Environmental Origin
Amphetamine
Ondansetron
Serotonin

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Serotonin Antagonists
Therapeutic Uses
Antipruritics
Dermatologic Agents
Tranquilizing Agents
Sympathomimetics
Gastrointestinal Agents
Central Nervous System Depressants
Central Nervous System Stimulants
Antipsychotic Agents
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Anti-Anxiety Agents
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 30, 2009